Chronic Obstructive Pulmonary DiseaseFOCuSEdNCT06390345
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
A study testing FOCuSEd Integrated Intervention in people with Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea, run by Seattle Institute for Biomedical and Clinical Research at 5 sites in United States.
Trial summary
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea, Overweight and Obesity
- What is being tested?
- FOCuSEd Integrated Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jul 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
- ≥10 pack year history of tobacco use
- Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
- BMI ≥ 25 kg/m2
- Symptoms of dyspnea defined by MMRC score of ≥1
Who cannot join
- Self-report of weight change >15 lbs. during prior 3 months
- Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
- Severe illness from any cause
- Diagnosis of bulimia or history of purging behavior
- Active enrollment in pulmonary rehabilitation
- Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy < 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.
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- Pregnant, lactating, or planning to become pregnant during the study period
- Participation in other intervention studies.
- Prisoner
- Unable to complete surveys in English
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Boise VA Medical Center
Boise, Idaho, 83702
Brianna Moss, brianna.moss@va.gov
Paula Carvalho, MD
- Recruiting
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
Brianna Moss, brianna.moss@va.gov
Min Joo, MD
- Recruiting
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
Brianna Moss, brianna.moss@va.gov
Charles Billington, MD
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Brianna Moss, 206.277.4166, brianna.moss@va.gov
Laura C Feemster, MD MS
- Recruiting
Mann-Grandstaff VA Medical Center
Spokane, Washington, 99205
Brianna Moss, 206-277-4166, brianna.moss@va.gov
Allison A Lambert, MD
About this study
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. < 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.
- Being tested
- FOCuSEd Integrated Intervention, Enhanced Usual Care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCuSEd Integrated InterventionOther
Participants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of ≥ 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.
Enhanced Usual CareOther
Participants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| FOCuSEd Intervention | Active comparator | Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. Receives: Other: FOCuSEd Integrated Intervention |
| Usual Care- Enhanced | Active comparator | For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SF-12 PCS
The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
Measured: 1 year
Secondary outcomes (24)
PROMIS Sleep-related impairment
The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
Measured: 1 year
PROMIS Sleep-related impairment
The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
Measured: 3 months
SF-12 PCS
The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
Measured: 3 months
SF-12 MCS
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Measured: 3 months
SF-12 MCS
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Measured: 1 year
PROMIS Sleep Disturbance
The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
Measured: 3 months
PROMIS Sleep Disturbance
The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
Measured: 1 year
COPD exacerbation or death
Proportion of patients with COPD exacerbation or Death (composite outcome) [ Time Frame: 3 months after randomization ]
Measured: 3 months
COPD exacerbation or death
Proportion of patients with COPD exacerbation or Death (composite outcome) [ Time Frame: 12 months after randomization ]
Measured: 1 year
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
Measured: 3 months
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
Measured: 1 year
Weight Loss
Total (kg)
Measured: 3 months
Weight Loss
Total (kg)
Measured: 1 year
Clinically Significant Weight Loss
5% weight loss met
Measured: 3 months
Clinically Significant Weight Loss
5% weight loss met
Measured: 1 year
Cardiovascular risk score
Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Measured: 3 months
Cardiovascular risk score
Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Measured: 1 year
Social Support
Social Support for diet and exercise scales
Measured: 3 months
Social Support
Social Support for diet and exercise scales
Measured: 1 year
Depression
PHQ-8 Depression scale
Measured: 3 months
Depression
PHQ-8 Depression scale
Measured: 1 year
Strength and endurance
30 second chair stand
Measured: 3 months
Strength and endurance
30 second chair stand
Measured: 1 year
OSA Severity
Home-Sleep Apnea Testing: Respiratory Event Index
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start29 Jul 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390345
- Sponsor's protocol ID
- 1766415
- Other IDs
- TE-2022C3-30598
- Acronym
- FOCuSEd
- Status last verified
- Jul 2026
- First submitted
- 25 Apr 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
- ClinicalTrials.gov ID
- NCT06390345
- Acronym / sponsor ID
- FOCuSEd / 1766415
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. < 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOCuSEd Intervention | Active comparator | Other: FOCuSEd Integrated InterventionParticipants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. |
| Usual Care- Enhanced | Active comparator | Other: Enhanced Usual CareFor participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
- ≥10 pack year history of tobacco use
- Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
- BMI ≥ 25 kg/m2
- Symptoms of dyspnea defined by MMRC score of ≥1
Key exclusion criteria (10 listed)
- Self-report of weight change >15 lbs. during prior 3 months
- Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
- Severe illness from any cause
- Diagnosis of bulimia or history of purging behavior
- Active enrollment in pulmonary rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOCuSEd Integrated InterventionParticipants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of ≥ 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. | Other | FOCuSEd Intervention |
| Enhanced Usual CareParticipants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider. | Other | Usual Care- Enhanced |
Primary outcome
The SF-12 PCS
Time frame: 1 year
The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
24 secondary outcomes
PROMIS Sleep-related impairment
Time frame: 1 year
PROMIS Sleep-related impairment
Time frame: 3 months
SF-12 PCS
Time frame: 3 months
SF-12 MCS
Time frame: 3 months
SF-12 MCS
Time frame: 1 year
PROMIS Sleep Disturbance
Time frame: 3 months
PROMIS Sleep Disturbance
Time frame: 1 year
COPD exacerbation or death
Time frame: 3 months
COPD exacerbation or death
Time frame: 1 year
COPD Assessment Test (CAT)
Time frame: 3 months
COPD Assessment Test (CAT)
Time frame: 1 year
Weight Loss
Time frame: 3 months
Weight Loss
Time frame: 1 year
Clinically Significant Weight Loss
Time frame: 3 months
Clinically Significant Weight Loss
Time frame: 1 year
Cardiovascular risk score
Time frame: 3 months
Cardiovascular risk score
Time frame: 1 year
Social Support
Time frame: 3 months
Social Support
Time frame: 1 year
Depression
Time frame: 3 months
Depression
Time frame: 1 year
Strength and endurance
Time frame: 3 months
Strength and endurance
Time frame: 1 year
OSA Severity
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCuSEd Integrated Intervention in people with Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea, run by Seattle Institute for Biomedical and Clinical Research at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brianna Moss (206.277.4166, brianna.moss@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The SF-12 PCS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.